I, Tony Ryall, Minister of Health, pursuant to section 96C(4) of the Medicines Act 1981 ("the Act"), hereby vary the conditional authorisation, issued under section 96C(1)
of the Act to Living Cell Technologies Limited (LCT) and dated the 22nd day of June 2009, to conduct a clinical trial involving xenotransplantation.
That authorisation is hereby varied in the following respects:
1. The protocol is amended as follows:
1.1 LCT is allowed to increase the number of participants in the study to 16.
1.2 LCT is allowed to increase the number of participants in the treatment arm where participants are administered 20,000 IEQ/kg to a total of 4.
2. Condition added:
2.1 LCT will, prior to implementing the amended protocol, provide Medsafe with evidence that
the Northern X Regional Ethics committee has considered and approved LCT’s proposed amendments contained in its application to Medsafe dated 26 March 2012.
All previous conditions instituted in the authorisation
issued to LCT and published in the New Zealand Gazette,
25 June 2009, No. 94, page 2111, remain in effect for
the period that the clinical trial has been approved by the Northern X Regional Ethics Committee, unless sooner varied or revoked, pursuant to section 96C(4) of the Act.
Dated this 22nd day of April 2012.
HON TONY RYALL, Minister of Health.